FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152630
·
Received June 22, 2011
Report
- Report Number
- 1720753-2011-08404
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE SOFTWARE, RESEATED THE PRINTED CIRCUIT BOARDS, AND REMOVED THE BLACK TAB ON THE BACKPLANE, AS WELL AS TIGHTENED U3 ON THE FLUORO FUNCTIONS BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A PRE CHARGE FAILURE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |